Efficacy of Short-message-based Re-education (SMRE) on Helicobacter Pylori Eradication

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Eradication Rate

Treatments: Behavioral: Short-message-based Re-education; Behavioral: conventional education

Study type: Interventional

Funder types: Other

Identifiers

NCT02833623

2016SDU-QILU-07

Details and patient eligibility

About

Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human population, resulting in high healthcare costs worldwide. However, H. pylori eradication rate is low nowadays and patients's compliance is one of the most important effective factors.

Enrollment: 310 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• outpatients aged 18-70 years
• confirmed diagnosis of H. pylori infection by at least one of the following methods: 13C-urea breath test, histology, rapid urease test or bacterial culture
• an intention of H. pylori eradication treatment and have written inform consent
• ability to read short messages on the mobile phone

Exclusion criteria

• advanced chronic disease that would not allow the patient to complete the treatment or follow-up or attend visits
• allergy to any of the drugs used in this study
• previous Helicobacter Pylori eradication treatment
• pregnancy or breastfeeding (female participants with childbearing potential were required to use medically accepted contraception for the duration of the study)
• taking antibiotics or PPIs or bismuth salts within four weeks
• previous gastrointestinal surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

Short-message-based Re-education group

Experimental group

Description:

Patients receive oral and written education before H. pylori eradication therapy at first, then they receive short message re-education twice per day during therapy. Both the content of the oral and written education and the short message re-education are same.

Treatment:

Behavioral: Short-message-based Re-education

conventional education group

Active Comparator group

Description:

Patients only receive oral and written education before H. pylori eradication therapy.

Treatment:

Behavioral: conventional education